ERBB2 (HER2/neu) Gene Amplification by FISH with Reflex, Tissue
Also known as: ERBB2 FISH
Use
This test aids in predicting the response to HER2-directed therapy in patients with breast carcinoma or gastroesophageal adenocarcinoma. It is used to confirm equivocal HercepTest (2+) immunohistochemistry (IHC) results. This test is vital in assessing the HER2 status, which is crucial for planning treatment strategies in relevant cancer patients.
Special Instructions
Include a surgical pathology report with the submission. If multiple specimens (blocks or slides) are sent, an order comment or individual orders for each sample must accompany them. A Pathologist Block Selection Fee will be added if the pathologist chooses the specimen. Unclear submissions will be held until clarification is provided.
Limitations
The test cannot be performed if the paraffin block has no tumor tissue remaining, if specimens are fixed in any fixative other than 10 percent neutral buffered formalin, or if specimens are decalcified. Specimens with fixation delayed for more than one hour or those fixed for less than 6 hours or more than 72 hours are also unacceptable.
FDA ApprovedNew York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 42783-1
- 42783-1
Result Turnaround Time
3-9 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Min 4 slides
Collection Instructions
Formalin fix (10 percent neutral buffered formalin) and paraffin-embed tissue. Fixative duration: 6-72 hours.
Storage Instructions
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Causes for Rejection
Paraffin block with no tumor tissue remaining. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens. Specimens with fixation delayed for more than one hour. Tissue fixed or less than 6 hours of greater than 72 hours.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |